Sr. Clinical Operations Specialist

  • Location
    Boston , Massachusetts
  • Category
    Medical & Science - Research
  • Job type
    Contract/Temp to Hire


A Clinical Operation Specialist job near Boston, MA is available courtesy of Adecco Medical & Science. Adecco Medical & Science is a division of The Adecco Group, a world leader in medical and scientific professional recruiting. Our client seeks an experienced clinical research or clinical operations professional with extensive medical device experience. This a senior to manager level opportunity by way of experience. Suitable candidates must have several years of clinical research within the medical device industry. You must have Site Monitoring, and Site start-up experience. Accountable key clinical research and clinical operational activities include working closely with clinical scientist(s) in the Department on study-related documentation, and clinical database.

Clinical Operations Specialist job responsibilities include:

Work closely with Sr. CPM to resolve study-related queries, and track and reconcile SAEs; oversight of Serious Adverse Event (SAE) reporting, and processing of reports
Oversee the execution of clinical trials in compliance with GCP/ICH, policies and procedures, and applicable local regulations
Develop and manage clinical study timelines, and quality guidelines alongside the Sr. CPM.
Accountable for operational review and input to protocol, ICF, and data collection instruments and responsible for development and compiling of key study documents


QUALIFICATIONS:

Ability to do at least 50% domestic travel
Minimum of Bachelor's Degree in a life sciences or related field required; Masters or PhD preferred
Minimum five to seven years of relevant clinical operations experience in Medical Device Industry, preferably as a clinical research associate or comparable.
Site Monitoring and site start-up experience is a must
Specialty training in I.D.E. preferably class II
Strong Knowledge of FDA and ICH Guidelines.



If you are interested in this Clinical Operations Specialist job in Boston, MA then please click APPLY NOW. For other opportunities available at Adecco Medical & Science go to www.adeccousa.com. If you have questions about the position, please contact Jonathon Blauvelt at jonathon.blauvelt@adeccona.com.


Equal Opportunity Employer Minorities/Women/Veterans/Disabled

  • Apply with Adecco

Reference number US_EN_2_106405_319841